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NCT02939183 · OUTCOME

Overall Response Rate (ORR) According to IMWG-URC

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks

What was measured

The ORR was defined as the percentage of participants with a BOR of sCR, CR, VGPR, and PR per the IMWG-URC. Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. The 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.

Analysis population: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.

Groups in this outcome

Oprozomib IR 150 mg/Day + Dexamethsone

In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib GR 150 mg/Day + Dexamethasone

In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.

Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone

In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Oprozomib IR 150 mg/Day + Dexamethsone3
Oprozomib GR 150 mg/Day + Dexamethasone6
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone3
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone7
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone5
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone10
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone8

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oprozomib IR 150 mg/Day + Dexamethsone66.7Not reported9.499.2Not reported
Oprozomib GR 150 mg/Day + Dexamethasone16.7Not reported0.464.1Not reported
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone33.3Not reported0.890.6Not reported
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone0.0Not reportedNANAThe 95% CIs could not be determined as no participants achieved OR.
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone85.7Not reported42.199.6Not reported
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone60.0Not reported14.794.7Not reported
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone60.0Not reported26.287.8Not reported
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone87.5Not reported47.399.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      2. group Id
        OG001
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      3. group Id
        OG002
        lower Limit
        0.8
        upper Limit
        90.6
        value
        33.3
      4. comment
        The 95% CIs could not be determined as no participants achieved OR.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        0.0
      5. group Id
        OG004
        lower Limit
        42.1
        upper Limit
        99.6
        value
        85.7
      6. group Id
        OG005
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60.0
      7. group Id
        OG006
        lower Limit
        26.2
        upper Limit
        87.8
        value
        60.0
      8. group Id
        OG007
        lower Limit
        47.3
        upper Limit
        99.7
        value
        87.5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      8
    units
    Participants
description
The ORR was defined as the percentage of participants with a BOR of sCR, CR, VGPR, and PR per the IMWG-URC. Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. The 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.
dispersion Type
95% Confidence Interval
groups
  1. description
    In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG000
    title
    Oprozomib IR 150 mg/Day + Dexamethsone
  2. description
    In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    OG001
    title
    Oprozomib GR 150 mg/Day + Dexamethasone
  3. description
    In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG002
    title
    Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
  4. description
    In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG003
    title
    Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
  5. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG004
    title
    Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
  6. description
    In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG005
    title
    Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
  7. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG006
    title
    Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
  8. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    OG007
    title
    Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
param Type
NUMBER
population Description
The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
reporting Status
POSTED
time Frame
Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks
title
Overall Response Rate (ORR) According to IMWG-URC
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice